Effect of Hydrotherapy on Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effect of Hydrotherapy on the Balance and Fatigue of Multiple Sclerosis Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06121648
• Other study ID #: 6006
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: November 2023
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this work was to investigate the effect of a hydrotherapy program on the balance and fatigue of patients with multiple sclerosis. it is a fact that hydrotherapy has an effect on the rehabilitation and treatment of people with balance problems.

Description:

26 patients with multiple sclerosis participated in the present research, who were divided into 2 intervention groups, one in the sea and one on land. The intervention program had a duration of 2 months with a frequency of 2 times a week for both groups. The interventions were performed by specialized therapists. All participants were assessed before and after the intervention using the BBS and MFIS scales.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 15, 2023
• Est. primary completion date: November 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 42 Years

Eligibility

Inclusion Criteria:

• diagnosed with RR-type (relapsing-remitting) multiple sclerosis by MS ( multiple sclerosis) expert neurologists, and Expanded Disability Status Scale (EDSS) cit 10 Score of 1-3.7 participated in this study.

Exclusion Criteria:

• older than 45 years; EDSS Score>3,7; primary progressive MS; acute or chronic physical or psychological disorders; participation in less than 12 of the 16 hydrotherapy sessions; common contraindications for hydrotherapy as cardiovascular disease, allergy etc.,

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• hydrotherapy
30 degrees temperature pool balance and breathing therapy
• neurological physiotherapy
Balance and neurological physiotherapy on land

Locations

Country	Name	City	State
Greece	University of Thessaly	Lamía	Central Macedonia

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (1)

1.Beck CA, Metz LM, Svenson LW, Patten SB. Regional variation of multiple sclerosis prevalence in Canada. Mult Scler 2005;11(5):516-9. 2.Corvillo I, Varela E, Armijo F, Alvarez-Badillo A, Armijo O, Maraver F. Efficacy of aquatic therapy for multiple sclerosis: a systematic review. Eur J Phys Rehabil Med 2017 [ahead of print]. 3.Multiple sclerosis: Hope through research. https://www.ninds.nih.gov/ Disorders/Patient-Caregiver-Education/Hope-Through-Research/MultipleSclerosis-Hope-Through-Research. Accessed October 1, 2018. 4. Ms prevalence: National multiple sclerosis society. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 2, 2018, 2018. 10 Kurtzke JF. Rating neurologic impairment in multiple sclerosis. Neurology 1983;33:1444. Alikhajeh, Y., Hosseini, S. R. A., & Moghaddam, A. (2012). Effects of hydrotherapy in static and dynamic balance among elderly men. Procedia-Social and Behavioral Sciences, 46, 2220-2224. Bekiari, M., Iakovidis, P., Lytras, D., Chatziprodromidou, I. P., & Dimitros, E. (2021). The effect of hydrotherapy on the symptoms and functional characteristics of multiple sclerosis patients. Int J Phys Educ Sport Heal, 8(2), 191-197. Castro-Sánchez, A. M., Matarán-Peñarrocha, G. A., Lara-Palomo, I., Saavedra-Hernández, M., Arroyo-Morales, M., & Moreno-Lorenzo, C. (2012). Hydrotherapy for the treatment of pain in people with multiple sclerosis: a randomized controlled trial. Evidence-based complementary and alternative medicine, 2012. Dixon, J., Hatton, A. L., Robinson, J., Gamesby-Iyayi, H., Hodgson, D., Rome, K., ... & Martin, D. J. (2014). Effect of textured insoles on balance and gait in people with multiple sclerosis: an exploratory trial. Physiotherapy, 100(2), 142-149. Genova, H., Dacosta-Aguayo, R., Goverover, Y., Smith, A., Bober, C., & DeLuca, J. (2020). Effects of a Single Bout of Aquatic Exercise on Mood in Multiple SclerosisA Pilot Study. International Journal of MS Care, 22(4), 173-177. Hammill, H. V., Ellapen, T. J., Strydom, G. L., & Swanepoel, M. (2018). The benefits of hydrotherapy to patients with spinal cord injuries. African journal of disability, 7(1), 1-8. Kahraman, T., Rasova, K., Jonsdottir, J., Medina, C. S., Kos, D., Coote, S., ... & Kalron, A. (2022). The impact of the COVID-19 pandemic on physical therapy practice for people with multiple sclerosis: A multicenter survey study of the RIMS network. Multiple Sclerosis and Related Disorders, 62, 103799. Kargarfard, M., Etemadifar, M., Baker, P., Mehrabi, M., & Hayatbakhsh, R. (2012). Effect of aquatic exercise training on fatigue and health-related quality of life in patients with multiple sclerosis. Archives of physical medicine and rehabilitation, 93(10), 1701-1708. Kubsik-Gidlewska, A. M., Klimkiewicz, P., Klimkiewicz, R., Janczewska, K., & Woldanska-Okonska, M. Z. (2017). Rehabilitation in multiple sclerosis. Advances in Clinical and Experimental Medicine, 26(4). Lambeck, J. (2017). Hydrotherapy in adult neurology. EWAC Medical http://www. ewac. com. Accessed, 10. Mooventhan, A., & Nivethitha, L. (2014). Scientific evidence-based effects of hydrotherapy on various systems of the body. North American journal of medical sciences, 6(5), 199. Ormstad, H., Simonsen, C. S., Broch, L., Maes, M., Anderson, G., & Celius, E. G. (2020). Chronic fatigue and depression due to multiple sclerosis: Immune-inflammatory pathways, tryptophan catabolites and the gut-brain axis as possible shared pathways. Multiple sclerosis and related disorders, 46, 102533. Tan, Z., Liu, H., Yan, T., Jin, D., He, X., Zheng, X., ... & Tan, C. (2014). The effectiveness of functional electrical stimulation based on a normal gait pattern on subjects with early stroke: a randomized controlled trial. BioMed research international, 2014.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BBS scale	The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.	2 months
Primary	MFIS scale	The total MFIS score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales.	2 months